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@ARTICLE{Schlenk:130491,
      author       = {R. Schlenk$^*$ and M. Lübbert and A. Benner$^*$ and A.
                      Lamparter and J. Krauter and W. Herr and H. Martin and H. R.
                      Salih and A. Kündgen and H.-A. Horst and P. Brossart and K.
                      Götze and D. Nachbaur and M. Wattad and C.-H. Köhne and W.
                      Fiedler and M. Bentz and G. Wulf and G. Held and B.
                      Hertenstein and H. Salwender and V. I. Gaidzik and B.
                      Schlegelberger and D. Weber and K. Döhner and A. Ganser and
                      H. Döhner},
      collaboration = {G. A. M. L. S. Group},
      title        = {{A}ll-trans retinoic acid as adjunct to intensive treatment
                      in younger adult patients with acute myeloid leukemia:
                      results of the randomized {AMLSG} 07-04 study.},
      journal      = {Annals of hematology},
      volume       = {95},
      number       = {12},
      issn         = {0939-5555},
      address      = {Berlin},
      publisher    = {Springer61936},
      reportid     = {DKFZ-2017-05570},
      pages        = {1931-1942},
      year         = {2016},
      abstract     = {The aim of this clinical trial was to evaluate the impact
                      of all-trans retinoic acid (ATRA) in combination with
                      chemotherapy and to assess the NPM1 status as biomarker for
                      ATRA therapy in younger adult patients (18-60 years) with
                      acute myeloid leukemia (AML). Patients were randomized for
                      intensive chemotherapy with or without open-label ATRA
                      (45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles
                      of induction therapy were followed by risk-adapted
                      consolidation with high-dose cytarabine or allogeneic
                      hematopoietic cell transplantation. Due to the open label
                      character of the study, analysis was performed on an
                      intention-to-treat (ITT) and a per-protocol (PP) basis. One
                      thousand one hundred patients were randomized (556,
                      STANDARD; 544, ATRA) with 38 patients treated vice versa.
                      Median follow-up for survival was 5.2 years. ITT analyses
                      revealed no difference between ATRA and STANDARD for the
                      total cohort and for the subset of NPM1-mutated AML with
                      respect to event-free (EFS; p = 0.93, p = 0.17) and
                      overall survival (OS; p = 0.24 and p = 0.32,
                      respectively). Pre-specified PP analyses revealed better EFS
                      in NPM1-mutated AML (p = 0.05) and better OS in the
                      total cohort (p = 0.03). Explorative subgroup analyses
                      on an ITT basis revealed better OS (p = 0.05) in ATRA
                      for genetic low-risk patients according to ELN
                      recommendations. The clinical trial is registered at
                      clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).},
      keywords     = {Tretinoin (NLM Chemicals)},
      cin          = {G040 / C060 / G100},
      ddc          = {610},
      cid          = {I:(DE-He78)G040-20160331 / I:(DE-He78)C060-20160331 /
                      I:(DE-He78)G100-20160331},
      pnm          = {317 - Translational cancer research (POF3-317)},
      pid          = {G:(DE-HGF)POF3-317},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:27696203},
      pmc          = {pmc:PMC5093206},
      doi          = {10.1007/s00277-016-2810-z},
      url          = {https://inrepo02.dkfz.de/record/130491},
}